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Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial
Sponsor: City of Hope Medical Center
Summary
This phase II trial tests how well dose-reduced docetaxel combined with cyclophosphamide works in treating older women with early stage (stage I-III) HER2 negative breast cancer vulnerable to toxicity. Chemotherapy drugs, such as docetaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Docetaxel and cyclophosphamide are commonly used, but is not well tolerated at the standard dose and can affect the way older patients feel physically and emotionally. Giving dose-reduced docetaxel combined with cyclophosphamide may be an effective treatment option and improve quality of life in vulnerable older women with stage I-III HER2 negative breast cancer.
Official title: Dose Reduction of Docetaxel-Based Chemotherapy in Vulnerable Older Women With Early-Stage Breast Cancer (DOROTHY)
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
174
Start Date
2024-09-16
Completion Date
2030-03-20
Last Updated
2025-10-09
Healthy Volunteers
No
Conditions
Interventions
Cyclophosphamide
Given IV
Docetaxel
Given IV
Medical Chart Review
Ancillary studies
Questionnaire Administration
Ancillary studies
Locations (2)
City of Hope Medical Center
Duarte, California, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States